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510(k) Data Aggregation

    K Number
    K250743

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-05

    (269 days)

    Product Code
    Regulation Number
    N/A
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Remvia NightGuard is indicated for:
    • Protection against teeth grinding, bruxism, and jaw clenching
    • Short-term pain relief from muscle spasm due to occlusal interference
    • Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

    Device Description

    The Remvia NightGuard is an intraoral appliance intended to mitigate the harmful effects of nocturnal bruxism. Remvia is retained within the posterior buccal vestibule and retromolar region, using anatomical support from safe, stress-bearing zones. The device does not cover dentition, thereby avoiding continuous occlusal loading and instead creating progressive resistance as clench force increases.

    AI/ML Overview

    N/A

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